Safety and Efficacy of ZTI-01 (IV Fosfomycin) vs Piperacillin/Tazobactam for Treatment cUTI/AP Infections

Inclusion Criteria

• A signed informed consent form (ICF);
• Male or female, at least 18 years of age;
• Diagnosis requires hospitalization and treatment with intravenous (IV) antibiotics;
• Documented or suspected cUTI or AP including at least 2 protocol defined signs and symptoms and a urine specimen with evidence of pyuria plus at least one protocol defined associated risk
• Pretreatment baseline urine culture specimen
• Expectation that any implanted urinary instrumentation will be removed or replaced not longer than 24 hours, after randomization;
• Expectation that patient will survive anticipated duration of the study;
• Patient requires initial hospitalization to manage the cUTI or AP;
• Women of childbearing potential have had a negative pregnancy test before randomization and be willing to consistently use a highly effective method of contraception
• Male study participants will be required to use condoms with a spermicide throughout study

Exclusion Criteria

• Presence of any of the following conditions: perinephric abscess, renal corticomedullary abscess, uncomplicated urinary tract infection, recent history of trauma to the pelvis or urinary tract, polycystic kidney disease, chronic vesicoureteral reflux, previous or planned renal transplantation; patients receiving dialysis/hemodialysis/CVVH, previous or planned cystectomy or ileal loop surgery; known or suspected infection; caused by pathogen resistant to study treatment antibiotics
• Presence of suspected or confirmed acute bacterial prostatitis, orchitis, epididymitis, or chronic bacterial prostatitis as determined by history and/or physical examination;
• Gross hematuria requiring intervention;
• Urinary tract surgery within 7 days prior to randomization or urinary tract surgery planned during the study period;
• Creatinine clearance 5 × ULN or total bilirubin >3 × ULN at Screening;
• Receipt of any potentially-effective systemic antibiotic with activity against Gram-negative uropathogens for more than 24 hours within the 72-hour window prior to randomization (exceptions defined in protocol);
• Requirement for additional systemic antibiotic therapy (other than study drug) or antifungal therapy for vaginal candidiasis;
• Likely to require the use of an antibiotic for cUTI or AP prophylaxis during the study;
• Known history of HIV virus infection and known recent CD4 count 480 msec;
• History of significant hypersensitivity or allergic reaction to fosfomycin, any contraindication to the use of piperacillin/tazobactam;
• Participation in a clinical study involving investigational medication or investigational device within the last 30 days prior to randomization;
• Inability, in the judgment of the Investigator, to tolerate the salt load required for study drug administration;
• Unable or unwilling, in the judgment of the Investigator, to comply with the protocol;
• Any patients previously randomized in this study.